510(k) K890053 ยท LSR Reagent, Borrelia Serological Reagent
MARDX LYME DISEASE IGG IFA TEST SYSTEM
| Applicant | Mardx Diagnostics, Inc., Scotch Plains NJ, US |
| Decision | Substantially Equivalent, Apr 18, 1989 |
| Received | Jan 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890053
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.